As is taught in the patent application noted above, it is becoming increasingly important to create temporary voids in bone or in spaces between bones, as for example, by the removal of the disc in the spine. In certain surgical procedures the operation creates a void that is wholly within the bone, and in other surgical procedures the void is completely through the bone and the depth of the void is predicated on the particular pathology being treated. When the medical procedure has been performed upon or through the bone, the surgically created void must be repaired to assure a successful surgical outcome and improve the healing process. The current state of repairing such voids is made up of three distinct categories; moldable fillers or flowable materials such as pastes, putties and cements; fixed dimension cages of various shapes including boxes, cylinders, and threaded devices which can be screwed into place; and adjustable devices. The final category of devices does allow some modification of the implant to fit the size of the void but only in a primarily symmetrical fashion. In other words, the height can be adjusted higher or lower by manipulating a threaded portion thus jacking it up or down, or other designs allowing for larger or smaller plates to be added to the side creating greater or lesser height. These adjustable devices allow for symmetrical adjustment but do not provide much or any ability to be adjusted asymmetrically to match irregularities in the bony void. Both sides along with the tops and the bottoms of these implants adjust to form a regular shape. Requiring the intraoperative creation of a near perfectly formed regular shape (polygonal) to receive the implant places an undo burden upon the surgeon by adding a difficult carpenter's task to the already complex task of performing the operation.
During a surgical procedure, the size and the shape of the void created in the bone will be dictated by a number of productive factors. These factors include; the patients anatomy, the procedure to be performed, the size, shape and make up of the pathology, the needed exposure for treatment, the size of the instruments needed to pass into or through the void, and among others, the surgeon's preferred technique. The reasons listed above, dictate the nature of the void created to treat the patient and achieve the surgical goals, which will lead to the overall well being of the patient. Those same reasons usually lead to a surgically created void that is not formed quadrilaterally, or cylindrically, or in some other symmetrically shaped configuration. These reasons usually dictate the creation of an irregular shape. Unfortunately, the medical community has not been provided with an adequately acceptable implant that accommodates these irregularly shaped configurations of the void. What is needed is an infinitely adjustable otherwise void-matching form-following implant made from a metallic or other material so as to supplant other filler techniques such as putties or cements, which are often not appropriate to fill a void. Heretofore, in these types of procedures that leave a void, the surgeon is burdened with the unfortunate task of adding complex carpentry to the final step of many orthopedic, neurosurgical, or other specialties' procedures. After the goal of the surgery has been accomplished the surgeon must unproductively modify the size and shape of the skeletal void solely for the purpose of shaping the void to receive an implant of the types that are currently available and which do not provide adequate adjustability. This situation provides an example of the age-old expression; you cannot put a square peg into a round hole. At this stage in a surgical procedure, in order to accommodate the shape of a selected implant it will often be necessary for the surgeon to remove substantial additional healthy tissue to create a void that matches the shape of the implant. In addition to the additional removal of healthy tissue being unproductive to the well being of the patient, it is often extremely difficult and time consuming. The purpose of this invention is to obviate these procedures as will be explained in further detail herein below.
A workshop-based carpenter is often privileged to work with a wide array of tools at his/her disposal. Maybe a large bench with table saws, jigsaws, clamps, glues, fillers, sandpaper and most importantly, plenty of time and space. Similarly, the biomedical implant engineers are usually working and developing their theories and prototypes in a lab on artificial bone models using machining tools such as a mill at a workstation or in otherwise, exacting non challenging environments, which make the creation of a perfect square, rectangle, ovoid, or some other predetermined engineering shape (regular shape) a practical task. A surgeon on the other hand, is almost always in a stressed and or otherwise challenged environment. The surgeon is usually working in a hole, a hole that is constantly oozing blood, working with sharp cutting implements while surrounded by delicate life preserving anatomical structures, limited in scope of movement, and often times with limited visualization among other frequent challenges. A surgeon is under terrific time constraints dictated by the health of the patient, the limitations and dangers of anesthesia, the continual bleeding of the now dissected patient, and more so today than ever before the present issues relating to the high hourly costs associated with running a hospital operating room. Any addition of time adds to and complicates these factors, likewise any reduction in time subtracts from these factors and works in the patient's favor. For the surgeon to spend several minutes to an hour or more performing carpentry tasks upon the iatrogenically created skeletal void solely for the purpose of modifying its form to receive a preformed or inadequately adjustable shape adds to all of the previously stated costs and subtracts from the overall well being of the patient. It is unfortunate, but this is the current state of the art and these events occur everyday in hospitals throughout the country and the world. The accommodation of a regular shape (the implant) by an irregular shape (the iatrogenically created skeletal void) requires the removal of additional skeletal tissue to modify the irregular shape into a regular shape to match the implant. If the shape of the skeletal void does not ultimately and adequately match the implant, the implant will have a poor fit and be at risk of not serving its desired function. This happens from time to time and can result in the implant migrating to an unplanned and undesirable location or other issues, many of which could require additional surgeries to repair the unplanned complication.
In accordance with this invention, we provide an implant that is inserted into the void and is adjustable to universally contact the irregular edges of the patient's bony anatomy. What is contemplated is that after the surgeon has performed a procedure upon or through a bone and created a skeletal void, without significantly altering the size and shape of void, we provide for the surgeon a series of the inventive implants which allows the surgeon to select one of the inventive implants that will most closely fit into the void, and then place the inventive implant selected, into the void and expand it universally to contact the irregular edges of the patient's bony anatomy in its current form. After the step of placing, expanding and tightening the implant into place, the implant can be filled with a biocompatible material according to the preference of the surgeon or the needs of the patient. Depending on the biocompatible material selected, or the preference of the surgeon, the surgeon may decide whether or not to place a cover over the implant. At this point the surgeon may move forward to complete the final steps of the surgery according to traditionally accepted medical procedures.
The object of this invention is to create a successful and repeatable method of surgically creating and repairing an operative pathway into or through bone. Also disclosed is a method for creating and repairing a surgically created void in bone that does not pass beyond the bone itself. It is common for surgeons to remove a bone in its entirety when it obstructs the surgical pathway to a targeted pathologic or anatomic target. This method of removing the entirety of the bone has historically been the standard of care and is commonplace today. This is primarily because there has not been an effective and predictably repeatable method of traversing bone to create a surgical pathway to perform a surgical procedure that also enabled the surgeon to repair and reconstruct the bone through which the surgical pathway was created.